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Quality Assurance Managers and Endpoint Adjudication

How the eAdjudication® "Quality by Design" Architecture eases your job

Ethical has designed and manages eAdjudication® processes according to global quality assurance and security standards. We have incorporated mechanisms to facilitate user validation of the system and we include a validation package and support in every offer we make. The eAdjudication® software system allows quick access to audit trails, full implementation of company-specific SOPs, and comes with an additional “mirror” environment where acceptance and change management testing can be executed throughout the study duration.

Ethical and eAdjudication® software and services simply make it easier for the Quality Assurance Manager to oversee Compliance and Quality of the Adjudication and decision-making process. Our software design and services comply with all pertinent ISO/IEC 27001 - EU General Data Protection Regulation (GDPR) requirements and controls. Our SOPs and electronic Record handling related to Clinical Processes and Quality Systems comply with all the relevant FDA and EMEA regulations.

An Integrated Quality Management System You Can Have Confidence In

Ready for Audits and Supplier Qualification Processes

For 20 years Ethical Staff gained experience working with many Sponsors, AROs and CROs for some 300 global clinical trials. We were always successfully qualified as Data Management and Software Services Providers, following a variety of processes and auditing procedures. So now our SOPs, Certifications, Documentation and Expertise are ready and available to support Your Qualification in the faster and most effective way.

Managed in an ISO/IEC 27001 - EU GDPR - Compliant Environment

Ethical’s software design and service provisioning are based on a hardware/software and organizational structure that ensures compliance with the ISO/IEC 27001 information security management system requirements and security controls. Data Privacy and Security is managed in compliance with the recent GDPR (EU General Data Protection Regulation).

Discover How eAdjudication® Simplifies Quality Assurance

We are EU-GDPR compliant: Your Data will never be used improperly

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DOWNLOAD Ethical's complete Endpoint Adjudication Charter Guide

Request your FRE copy of the Adjudication Charter Guide built by Ethical after reviewing more than 20 study charters. Adjudication charters are a key element for the setup of quality Adjudication procedures and have been developed in various formats.

Endpoint Adjudication Data for Submission to FDA and EMA - What Should Be Included?

Are you planning to submit Endpoint Adjudication Data to the FDA or the EMA? Submitted material are not only essential for obtaining marketing authorization but also a reflection of the quality of your company’s work.

About Ethical

Ethical GmbH is an eClinical Company focused on Endpoint
Adjudication. Our
approach is based upon our staff’s experience providing software solutions to support some 300
international
clinical trials with more than 10,000 investigator sites and hundreds of thousands of patients.
Our solution
was shaped by the insight that AROs, CROs, and clinical trial sponsors need an Endpoint
Adjudication
platform and software solution that is easier to implement and for their study teams, data
reviewers and
adjudication committees to use. The result — a combination of out-of-the-box, effective Endpoint
Adjudication software features with complete technical infrastructure management that employs a
cloud
software-as-a-service provisioning model.